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["1 T M W N U M S T N 14 N W _ N M 'W W T'EL M _'E@OWWj@._ ,_|| NRC FORM 374 1
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Amendment No. 07- : MATi' RIALS LICENSEi
; Pursuant to the Atomic Enzrgy Act of 1954, as amended, the Energ) Reorganization Act of 1974 (Public Law 93 4Hl. and Title 10.Code of I ederal le gulanons. Chapter 1. Parts 30,31. M,33. 34, 35. 39,40 and 70, and in reliance on statements aod representations heretoforei q e
! 4 made by the Inensee, a heenw n hereby mued authorising the licenwe to receise, acqdre, poness, and transfer byproduct, source, and speculi { nuclear matt rial desipriated bel 0*; to uw such material for the purpose (s) and at the place (s) designated below; to deiner oc transfer such material
i I to pumns authorized to receise it in acwrdant e with the regulations of tbc applicable Part(so This hcense shall be deemed to contain the conditions
i socified in Section 183 of the A: c.ie Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear1
g Regulator) Comminion now or hereafter la effect and to any conditions specified below.-
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! ( bcensee |4{ in accordance with Ictter dated January 18,1991'
4; |4' g Ponce District llospital 3. Ucense number $21153401
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4 is amended in its entirety to read as rollows:
! k, hiachuelo Road 14 =
| Ponce, Puerto Rico 00731"
4. Expiration date February 28,19971 4'j
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5. Docket or 030-035274q- Reference No
,
j ,4, 6 Byproduct, source, and/or 7. Chemical and/or physical 6. hiaxirnum amount that licensee4 special nuclear material form may possess at any one time
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f ender this license,
4j A. Any byproduct material A. Any radiopharmaceutical A. 'As neededidentiGed in 10 CFR 35.100 identified in 10 CFR 35.100< .
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!i D. Any byproduct material B. Any radiopharmaceutical B. A's needed^
identified in 10 CFR 35.200 identified it; 10 CFR 35.200!
'q! except gases and acrosols til!
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Any byproduct material C. Any radiopharmaceutical C. As needed (Not to exceed 10 h.'
1
Eidentified in 10 CFR 35.300 - identified in 10 CFR 35.300 curies of iodine)(iodine in capsule form only) q
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%i D. Any byproduct material D. Prepackaged Kits D. As needed - >
@di identified in 10 CFR 31.11
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9. Authori/cd Use: (!p.
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ij A. hiedical use described in 10 CFR 35.100.-
. f B, hiedical use described in 10 CFR 35.200, except procedures using gases or aerosols.i g C. hiedical use described in 10 CFR 35.300 (iodine in capsule form only). h*y D. In vitro studies. y*
L 16'q: pk CONDITIONS . M(' h'
i 10. Location for use: Ponce District ilospital fd hiachuelo Road 14i g
; 4 Ponce, Puerto Rico y
di OG01G3 j-i
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)( MATERIALS LICENSE gg, y,g,, g, Q4 SUPPLEMENTARY SHEET 030 03527 I"1
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Amenament No. 07i
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f,CONDITIONSContinued-
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11. Radiailon Safety Officer: Evelyn Cintron Ruir, M.D. >A
$ 1i 12. Authorized user:4 |
>(g; A. Evelyn Cintron Ruir, M.D. 1)i
|I,4 13. Scaled somces containing licensed material s n' not be opened by the licensee. I4 !!-k 14. In addition to the possession limits in item 8, the licensee shall further restrict the possession of licensed material
{i[f to quantities below the minimum limit specified in 10 CFR 3035(d) for establishing decommissioning rmancialg bassurance,
15. The licensee shall maintain records of information important to safe and effective decommissioning at the licensce's !
$ facilities listed in Condition-10 per the prosision of 10 CFR 3035(g) until this license is terminated by the kf Commission. -
f
f Except as specifically provided otherwise in the license and as provided in 10 CFR 35.51, the licensee shall conducti, _
.
h its program in accordance with statements, representations, and procedures contained in the documents including4j any enclosures, listed below, The Nuclear Regulatory Commission's regulations shall govern unless the <tatements,
"f representations and procedures in the licensee's application and correspondence are more restrictive that the ;|'g4
regulations.g
A. Application with attachments dated January 18, 19710
i4 B. A1 ARA Program dated January 18,1991 j,
1C, Letter dated February 4,1992
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(j - FOR Tile U. S. NUCLEAR REGULATORY COMMISSION14; -
EARL G. WRIG!!T-
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Date FEB 241992 d4 Mas /~ l~
ny% Region 11, Nuc! car Materials Saf tf Section ;y
101 Marietta Street, Suite 2900;
, Atlanta, GA 30323|
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ESTADO DE ASOCIADO DE PUERTO RICODEPARTAMENTO I?t sal.UD
; ilOSPITAls REGIONAL, DE PONCE -
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I)r Andr6s Delanoy Corominas 1.uisa Carraquillo, MilSA. RRADirector lheuttad Interino Directora 1 jecutn a
i !cda hime Maldonado Rherm MSilA %r Gabrki lhlriguez SotoAdmimstmdor Awiado l uncionario l~jecutwo
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libruary 4,1992
U.S. Nuclear Regulatory Commission*
Region 11-Material Radiation Section,
101 hiarictta St. - Suite 2900'
Atlanta, GA 30223
Alail ControlNo. 253930i Subject: Licence Renewal Additional Information
Gendemen:
Thefollowing additionalinformation is submitted in response to your request.
Item 1. He will not usa Xenon gas or iodine in liquidform or any otherpotentially volatilematerial.
,
Item 2. Thefollowing air the action levels established in our laboratory,i
ErternalRadiation: Removable Surface Contamination
l 1. RestrictedArva: 2,000 dpm.! 5 mrlm at ift.
| 2. UnrestrictedArea: 200 dpm
item 3: Bionssays
| Alliodine in ourlaboratory willbe used in capsules even for therapeutic pmposes.| The vials containing the capsules me maintained at the hot room behind a lead
nest. Under no cittwnstance the activity levels indicated in table 1 of RegulatoryGuide K20 will be etceeded. All therapeutic doses arefor hyperthyroidism cases.
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U. S. Nuclear Regulatory CinnmissionPage 2February 4,1992
liem 4. Radiochemicalnone Hoodi
ill have a metal wall mounted hood installed at the time of the laboratoryconsinterion. Even when as mention before no volatilefinnes will be used, thehond is considered adequal: because the same type is in stalled at the chemistry andblood laboratory where toxic gases am handled Allpertinent agencies like ElbfandJoint Cinnmission has inspr eted those hoods with no adversefindings.
At the present time thefwne hood is not necessary because we will not useraadioactive gases nor liquid radioiodine.
Ifl trquest the dealy in answering your letter. Let us know iffurther information is needed..
Sincerely,
CL. a % 9Luisa L Carrasq'tillo, AlH&l, RR4Executive Director
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OFFICIAL RECORD COPYFEB 111992
Ponce District Regional HospitalATTN Ms. Luisa Carrasquillo
Executive DirectorMachuelo Road 14 ,
Ponce, PR 00731
Gentlemen:
SUBJECT: REQUEST FOR MORE INFORMATION ABOUT YOUR MATERIALS LICENSEAPPLICATION (REFERENCE: 253936; 030-03527)
This refers to our letter of November 5, 1991 in which we requestedmore informction about your application of January 18, 1991. Thisalso refers to a telephone conversation of January 15, 1992 betweenHector Bermudez of NRC, RII and your consultant, Daniel Torres. Itis our understanding from this telephone conversation that you willprovide a response to our November 5, 1991 letter no latter thanclose of business February 20, 1992.
Unless we receive a resporse as promised, it may be necessary forNRC to issue an order requiring that you divest yourself of alllicensed material and show cause why your license should not beterminated.
If there is some valid reason why you cannot provide theinformation by the date specified, please call me immediately at404-331-5617.
Sincerely, .fy ;3Q | , ,jg:- r m 4
Earl G. WrightSenior License ReviewerNuclear Materials Safety Section
Enclosures:1. NRC ltr. dtd. 11/05/91cc:Evelyn Cintron Ruiz, M.D.Daniel Torres
hd RII(Wright CHosgy
2/({AM(/
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[,cM, ,, " %,4,,e UNITED ST Af ts ,9*
. NUCLEAR REGULATORY COMMISSION $.* n RtolON il/p/y,#
* r g 101 MARitTTA STRttT.N W.t ATL ANT A. GEORGI A 30323
NOV 05199| (\\...../Ponce District Regional Hospital km)ATTH: Ms. Luisa Carrasquillo
Executive Director *
Machuelo Road 14Ponce, PR 00731
Gentlemen:
SUBJECT: REQUEST - FOR MORE INFORMATION ABOUT YOUR MATERIALS LICENSEAPPLICATION (REFERENCE: 253936; 030-03527)
In order to continue the review of your application datedJanuary 18, 1991,-we need the following additional information:1. KATERIALB TO BE USED. Is it your intention to use Xenon gasor iodine in liquid form or any other potentially volatile
material? If so, please. refer to Appendix 0 of the enclosedReg Guide 10.8 (Rev-2) and provide us with a complete descrip-tion of your procedures for maintaining control of potentialairborne concentrations of these licensed materials.
2. ACTION LEVEL 8. In Item 10.12 of your application you committo area survey procedures specifieL in Appendix N ofReg Guide 10.8 (Rev 2). However, you did not establish actionlevels for external radiation and for removable surface con-tamination. These levels are required in order'to dictatewhen you will take action to prevent a potentially hazardoussituation. Accordingly, we ask that you refer to Table N-1 ofAppendix N and provide us with your. action levels.
3. BIOASSAYS. Since you have requested authority to useiodine 131 for tperapeutic purposes, plot describe yourbioassay proceddres- for complying with 10 CFR 35.315(a) (8) .(10 CFR 35 and Reg Guide 8.20 are enclosed for reference.]
4. RhDIOCHEMICAL FUME HOODB. You stated in your application thata fume hood is available for use in your nuclear medicineprogram. However, no specifications for either the hood orits installation were included. Please provide the following:
* Type and general description of the--hood includingmaterials of construction;
* Face velocity (normally 100 linear feet / minute) ;-
* Filtration (may require absolute filter for particu-lates or activated charcoal for iodine depending upon theform and quantitles to be used); '
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Ponce District Regional Hospital-21
* Exhaust stack location, effluent release point (notetthe release point should normally be at least 12' feet-
above the. highest point of the building in' order toprevent recirculation of potentially contaminated-air.into fresh air intakes).
Please provide the requested information within 30 days of receiptof this letter in order that we be able to continue our review of-your application.
When replying, please provide 2 copies of the requested informationand refer to Mail Control No. 253936.If you have questions about'this letter, please call me at404/331-5617.
Sincerely,
ORIGINAL stGNFD BYEARL G V/RIGHT
Earl G. WrightSenior License ReviewerNuclear Materials Safety Section-
Enc 1:1. 10 CFR 352. Reg Guide 8.20
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{ ,j 101 MAnit1T A STREE T, N.W. h,t At L ANT A, GEORGI A 30373 /
k . . . . #'' NOV 051991 \(4)Ponce District Regional Hospital
ATTN: Ms. Luisa CarrasquilloExecutive Director
Machuelo Road 14Ponce, PR 00731
Gentlemen:
SUBJ ECT: REQUEST FOR MORE INFORMATION ABOUT YOUR MATERIALS LICENSEAPPLICATION (REFERENCE: 253936; 030-03527)
In order to continue the review of your application datedJanuary 18, 1991, we need the following additional information:
1. MATERIALS TO DE USED. Is it your intention to use Xenon gasor iodine in liquid form or any other potentially volatilematerial? If so, please refer to Appendix 0 of the enclosedReg Guide 10.8 (Rev 2) and provide us with a complete descrip-tion of your procedures for maintaining control of potentialairborno concentrations of these licensed materials.
2. ACTION LEVEL 8. In Item 10.12 of your application you committo area survey procedures specified in Appendix N ofReg Guide 10.8 (Rev 2). However, you did not establish actionlevels for external radiation and for removable surface con-tamination. These levels are required in order to dictatewhen you will take action to prevent a potentially hazardoussituation. Accordingly, we ask that you refer to Table N-1 ofAppendix N and provide us with your action levels.
3. BIOASSAYB. Since you have requested authority to useiodine 131 for therapeutic purpaces, please describe yourbionssay proceddres for complying with 10 CFR 35.315(a)(8).[10 CFR 35 and Reg Guide 8.20 are enclosed for reference.]
4. RADIOCHEMICAL FUME HOODB. You stated in your application thata fume hood is available for use in your nuclear medicinoprogram. However, no specifications for either the hood orits installation were included. Please provide the following:
* Type and general description of the hood includingmaterials of construction;
* Face velocity (normally 100 linear feet / minute) ;
* Filtration (nay require absolute filter for particu-lates or activated charcoal for iodine depending upon theform and quantitles to be used);
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'Ponce District Regional llospital 2
* Exhaust stack location, effluent release point (note:the release point should normally be at least 12 feetabove the highest point of the building in order toprevent recirculation of potentially contaminated airinto fresh air intakes).
Please provide the requested information within 30 days of receiptof this letter in order that we be able to continue our review ofyour application.
When replying, please provide 2 copies of the requested informationand refer to Mail Control No. 253936.If you have questions about this letter, please call me at404/331-5617.
Sincerely,
ORIGINAL siGyre gy
EARL G v/ RicinEarl G. WrightSenior License ReviewerNuclear Materials Safety Section
Encl:1. 10 CFR 352. Reg Guide 8.20
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- ~ _ , . . _ _ ___.._.__.:~_- . CEC R- L EES _U S E L_._ _ - __: INFORMATION FROM LTS
O aerwuN: : ______________________ __
:1IC'iNSE FEE MANAGEMENT BRANCH, ARM := PROGRAM-CODE: 021200 ANo : status C0os: 22E-GIOrmL. LICENSING ~5ECTIONS - _ .. _ _._: _EE E_ C A T EG D R YLE LJ C ____.._--
: EXP. DATE. 19910223O : #Ee COMMENTS: 1To.ucA>cs)_C00E_16;
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O LICcNsE reE TRANsxITTAt~ ~~ '
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A. REGION
1. A PPLIC ATION ATTACHEDAPPLIC ANT / LICENSEE:- . PONCE _ DISTRICT _ cREGION AL-). HOSPIT AL -
O aECEIveo cATe: 91oI29-_ 000AET ND:. . _. _ 3003521 . _ _ . - _- - _
CONTROL NO.: 253936O LICENSE _NO.:-_ .-52-11535 01. . - - . - _ . _ - _ . _ . . _ . _ . - . . _ _
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ACTION TYPE: RENEWAL Y
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Twt Ap%tCANT AND ANv OFf tCIAL t RECUTeNG THtS Cintt8tCATION 04 StMALF 08 THE APPtacANT.NautD 18e litu 2 CERTI8 7 TM AT Tuis ApeuCATION t$1 PRf P ARED IN COnef 0 Rusty wiTM TITLE 10 CODE 08 f tDER AL REGULAT40NS. PARTS 30. 37. 33. 3A. 3%, ANO 40 A*e0 T6eA T ALL 4NFORMATION CONT AINED MSRenN,i -..
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te U S C StCTION toot ACT OF JUNE 26.194e 67 ETAT 749 Wat ts if a CawiN AL OsttNSE To u4a t A WILLFULLY f AL$t $T ATGWENT OR REPRG$ENT ATION! w a nae:NGTO ANT OtPActTWt NT OR AGENCY Of THE uantt0 ST AtES AS TO Ahv W ATTER wtTMim tT3 JuRi30ICTION
StGN ATURE -Ct Rit9 4 4NG OD F ICER T1PtOSR4NTED NAML TITLt . Daft
Luisa Carrasquillo Executive Director J.muary 18/91?' a"
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APPENDIX G ., ,
Model Program for Maintaining Occupational Radiation Exposure '
9 at Medical Institutions ALARA(See 6 35.20.)
You may use the text as it appears here, saying on your application, "Wewill establish and implement the model ALARA program that was published inAppendix G to Regulatory Guide 10.8, Revision 2."
IfIf you prefer, you may develop your own ALARA program for NRC review.
you do so, you should consider for inclusion all the features in the model andSay on your application, "Wecarefully review the requirements of 6 35.20.have developed an ALARA program for your review that is appended as ATT 10.2,"and append your program.
ALARA PROGRAM
PONCE DISTRICT RECTONAL ll0 SPITAL(Licensee's Name)
I n n ita r y 18. 1991(Date)
1. Management Commitment
We, the management of this (medical facility, hospital, etc.), area.committed to the program described herein for keeping individual and
9 collective doses as low as is reasonably achievable (ALARA). Inaccord with this commitment, we hereby describe an administrative-
organization for radiation safety and will develop the necessarywritten policy, procedures, and instructions to foster the ALARAconcept within our institution. The organization will include aRadiation Safety Committee (RSC) and a Radiation Safety Officer (RS0).
b. We will perform a formal annual review of the radiation safety program,including ALARA considerations. This will include reviews of operatingprocedures and past dose records, inspections, etc., and consultationswith the radiation safety staff or outside consultants.
Modifications to operating and maintenance procedures and to equip-c.ment and facilities will be made if they will reduce exposures unlessthe cost, in our judgment, is considered to be unjustified. We willbe able to demonstrate, if necessary, that improvements have beensought, that modifications have been considered, and that they havebeen implemented when reasonable. If modifications have been recom-mended but not implemented, we will be prepared to describe thereasons for not implementing them,
In addition to maintaining doses to individuals as far below the limitsd.as is reasonsbly achievable, the sum of the doses received by allexposed individuals will also be maintained at the lowest practicable
G-1
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level. It would not be desirable, for example, to hol,d the highest idoses to individuals to some fraction of the applicable limit if thisinvolved exposing additional people and significantly increasing thesum of radiation doses received by all involved individuals. I
2. Radiation Safety Committee
a. Review of Proposed Users and Uses
(1) The RSC will thoroughly review the qualifications of each appli-cant with respect to the types and quantities of materials andmethods of use for which application has been made to ensurethat the applicant will be able to take appropriate measures tomaintain exposure ALARA.,
(2) When considering a new use of byproduct material, the RSC willreview the efforts of the applicant to maintain exposure ALARA. ,
!
(3) The RSC will ensure that the users justify their proceduresand that individual and collective doses will be ALARA.
4 b. Delegation of Authority
(The judicious delegation of RSC authority is essential to theenforcement of an ALARA program.)
(1) The RSC will delegate authority to the RSO for enforcement ofthe ALARA concept.
(2) The RSC will support the R50 when it is necessary for the R50to assert authority. If the RSC has overruled the RSO, it willreccrd the basis for its action in the minutes of the quarterlymeeting,
Review of ALARA Programc.
4
(1) The RSC will encourage all users to review current proceduresand develop new procedures as apprupriate to implement theALARA concept.
(2) Tne RSC will perform a quarterly review of occupational radiation '
exposure with particular attention to instances in which theinvestigational levels in Table 1 are exceeded. The principalpurpose of this review is to assess trends in occupational expo-
;
sure as an index of the ALARA program quality and to decide if|i
action is warranted when investigational levels are exceeded (see (Section 6 below for a discussion of investigational levels).*|r
*The NRC has emphasized that the investigational levels in this program arenot new dose limits but, as noted in ICRP-Report 26, " Recommendations of theInternational Commission on Radiological Protection," serve as check pointsabove which the results are considered sufficiently important to justifyinvestigations.
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Table 1 ,
I'nvestigational Levels
- _ . Investigational ' Levels '
(mrems.per calendar quarter)
Level I Level II
1. Whole body; head and trunk; 125 375-
active blood-forming organs;lens of eyes; or gonads
2. Hands and forearms; feet 1875 5625
and ankles
3. Skin of whole body * 750 2250
*Not normally applicable to medical use operations except thoseusing significant quantities of beta-emitting isotopes.-
The RSC will evaluate our institution's overall efforts. for-
(3) maintaining doses ALARA on an annual basis. This reviewwill include the efforts of the'RSO, authorized users, and
-
workers as well as those of management. .
3. Radiation Safety Officer
Annual and Quarterly Review-a.
The RSO will=Annual review of the radiation safety program.(1)perform an annual review of the radiation-safety = program foradherence to ALARA concepts. - Reviews .of- specific methods of <
'
use may be conducted on a more frequent basis.l
The R50 will reviewQuarterly review of occupational exposures.(2) at least quarterly the external radiation doses of authorizedusers and workers to determine that their doses are ALARA-inaccordance with-the provisions of Section 6'of this program andwill-prepare a summary report for the RSC.
Quarterly review of records of radiction surveys The RSO will(3) review radiation surveys in unrestricted and restricted areas
-to determine that duse rates and amounts of contamination were~
at ALARA levels during the previous quarter and will prepare asummary report for the-RSC.
b. Education Responsibilities for ALARA Program --
(1)- The RSO will schedule briefings and educational sessions toinform workers-of ALARA program efforts.
G-3
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s
.
(2) The RSO will ensure that authorized users, workers., and ancillapersonnel who may be exposed to radiation will be instructed inthe ALARA philosophy and informed that management, the RSC, andthe RSO are committed to implementing the ALARA concept.
Cooperative Efforts for Development of ALARA Proceduresc.
Radiation workers will be given opportunities to participate informulating the procedures that they will be required to follow.(1)
The RSO will be in close contact with all users and workers inorder to develop ALARA procedures for working with radioactivematerials.
(2)The RSO will establish procedures for receiving and evaluatingthe suggestions of individual workers for improving healthphysics practices and will encourage the use of those procedures
d.Reviewing Instances of Deviation from Good ALARA Practices
The RSO will investigate all known instances of deviation from goodALARA practices and, if possible, will determine the causes. Whenthe cause is known, the R50 will implement changes in the program tomaintain doses ALARA.
4. Authorized Users
New Methods of Use Involving Potential Radiation Dosesa.
(1)The authorized user will consult with the RSO and/or RSC duringthe planning stage before using radioactive materials for newuses.
(2) The authorized user will review each planned use of radioactivematerials to ensure that doses will be kept ALARA. Trial runsmay be helpful,
b. Authorized User's Responsibility to Supervised Individuals
(1) The authorized user will explain the ALARA concept and the needto maintain exposures ALARA to all supervised individuals.
(2) The authorized user will ensure that supervised individuals whoare subject to occupational radiation exposure are trained andeducated in good health physics practices and in maintainingexposures ALARA.
5. Individuals Who Receive Occupational Radiation Ooses
Workers will be instructed in the ALARA concept and its relation-a.
ship to work procedures and work conditions,b.
Workers will be instructed in recourses available if they feel thatALARA is not being promoted on the job.
G-4
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Establishment of Investigational Levels in Order to Monitor, Individualllary
Occupational External Radiation Ooses6
d
This institution hereby establishes investigational levels for occupa-tional external radiation doses which, when exceeded, will initiate reviewThe investigational levelsor investigation by the RSC and/or the R50. These levels apply to thethat we have adopted are listed in Table 1.exposure of individual workers.
The R50 will review and record on Form NRC-5, " Current OccupationalExternal Radiation Exposures," or an equivalent form (e.g. , dosimeterprocessor's report) results of personnel monitoring not less than once
"The
in any calendar quarter as required by S 20.401 of 10 CFR Part 20.e
following actions will be taken at the investigational levels as stated9 in Table 1:
Personnel dose less thLn Investigational Level I.res- a.1
Except when deemed appropriate by the R50, no further action will betaken in thnse cases where an individual's dose is less than Table 1
J values for the Investigational Level I.
Personnel dose equal to or greater than Investigational Level I but;0 b. less than Investigational Level II.
The R50 will review the dose of each individual whose quarterly doseequals or exceeds Investigational Level I and will report the resultsof the reviews at the first RSC meeting following the quarter whenthe dose was recorded. If the dose does not equal or exceed Investi-
9 gational Level II, no action related specifically to the exposure isThe Committee9 required unless deemed appropriate by the Committee.will, however, review each such dose in comparison with those of othersperforming similar tasks as an index o ALARA program quality andwill record the review in the Committee minutes.e
Personnel dose equal to or greater than Investigational Level II.c.! investigate in a timely manner the causes of all person-The R50 will| nel doses equaling or exceeding Investigational Level II and, if
warranted, will take action. A report of the investigation, anyd. actions taken, and a copy of the individual's Form NRre5 or itst
equivalent will be presented to the RSC at its first meeting follow-ing completion of the investigation. The details of these reports
)will be included in the RSC minutes.
Reestablishment of investigational levels to levels above thoseI d.
listed in Table 1.In cases where a worker's or a group of workers' doses need to exceedan investigational level, a n'w, higher investigational level maybe established for that individual or group on the basis that it is
| consistent with good ALARA p actices. Justification for newI
investigational levels will be documented.
,
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The RSC will review the justification for and must approve ordisapprove all revisions of investigational levels. ;
7. Signature of Certifying Of ficial*
I hereby certify that this institution has implemented the ALARA Programset forth above.
,-i8k un '( p(L4rtG2,'f'LLO'',
Signature
LUISA CARRASQUILLOName (print or type) >
EXECUTIVE DIRECTOR |Title i
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( "The person who is authorized to make commitn.ents for the administration oftha institution (e.g., hospital administrator).
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Radioactive material for' medical use.
Item 5 By Product Material Chemical or Physical Forg. Maximum Amount
1. I 131 1. Na iodide 300 mei
2. Tc 99m 2. Pertechnetate as needed ,
3. Molybdenum 99 3. Mo 99/tc generator 2,000 mei
4. Technorium 99m 4. Labeled aggregated as needed-human. serum albumin ;
5. Technetium 99m 5. Labeled sulfur colloid as-needed
6. Technetium 99m 6. Labeled Sn pyrophosphate zus needed
7. Technetium 99m 7. Labeled Sn polyphosphate as needed
8. Technetium 99m 8. Labeled di Na Medronate as needed
9. Technetium 99m 9. Labeled di Na etidronate as needed-
10. Technetium 99m 10. Labeled DTPA tin complex as needed
11. Tc-99m 11. Labeled DTPA aerosol as needed
12. Technetium 99m 12. Labeled disofenin as needed
13. Tc-99m 13.-labeled comercial~Kits for myocardial
,
cerebral perfusion as needed
14. Gallium 67 14.-gallium-citrate as needed
15. Thallium 201 15. Thalium 201- as needed,
|
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16 . I 125, or I 131 17. Radioimmunoassay: Kits:- 3 meiDigoxin, Digitoxin, Renin,:HGH, Cortisol, Insulin,HPL, ACTH, Gastrin, T3, T4,TSH.i
j (commercial kits) for antigens'antibodies, drugs levels detection,
i17 Any by product 18. Maximum Amounts as necessary
material or any _for authorized usesradiopharmaceuticalfor studies in35.200 and-35.100 of-10 CFR Part -35
. -.-
:-
|
Items S 6j
Dy Product Material Amount Purpose
I Radiopharmaceuticals- as needed uptake, dilution,approved by PDA as and Excretionin 35:100 of 10 CFR 35 studies
II Radiopharmaceuticals as needed Imaging andgenerators, reagent ~ localizationkits as approved by studiesFDA as in 35:200 of10 CFR 35
Generators will be eluted and reagentsKits will be prepared in accordance withthe manufacturers instructions.
III Padiopharmaceuticals up to 30 mei treatment offor therapy . hyperthyroidism,-
thyroid _ ablation.
iodide 131 up.to 300. mci treatment ofthyroid carci -noma
Instructions in-package insert'regardingindications and method of administration.will be-followed.
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Item 6:
Isotope Form Purnose Dose
1. I 123 iodide thyroid function tests
2. I 131 iodide thyroid function testa
3. I 131 iodide Treatment of hypers "- Up to 30 meithyroidism, thyroidablation
4. I 131 iodide Treatment of thyroid up to 300 meicarcinoma
5. Tc 99m pertechnetate Blood pool imaging- 20-30 mei
6. pertechnetate Thyroid scan- 10-12 mci
7. Mo 99 Mo-99/tc 99m Generator
8. Tc 99m Labeled aggre- Perfusiongated-Human albumin Lung scan 2-4 mci
9. Tc 99m Labeled sulfur Liver _and spleen scan. _1-8 mc1colloid
,
10. Tc 99m Labeled Sn Bone imaging 10-30 meipyrophosphate adult-dose
11. Tc 99m Labeled Sn | Bone-imaging 10-30 meipolyphosphate adult dose
12. Tc 99m Labeled di na Bone _ imaging 10-30 mcimedronate adult dose
13. Tc 99m Labeled di na Bone imaging- 10-30 meietidronate adult dose
14. Tc 99m Labeled DTPA Kidney function ~10-20 mcitin complex adult dose
15. Tc-99m Labeled aerosol Pulmonary ventilation 25-30 mei/cc solu
16. Tc 99m pertechnetate Abdominal scan 10-25 mei:
h(9ckels)
.. .
____-_____ $
_..
.. ..
. ..
.
Isotope Form Purpose (Uses) Dose
17. Tc 99m pertechnetate Testicular scan 10-25 mei
18. Tc 99m pertechnetate Parotid gland scan 10-20 meifunction
19. Tc 99m Labeled disofe- Hepatobiliary B-l' meinin or IDA imaging
20. Tc 99m Labeled pyrophos- cardiac imaging 20-30 mciphate
21. Tc 99m in vivo labeled cardiac imaai..g 20-30 meiRBC (ventricula. -al'
function)22. Tc 99m in vivo labeled gastrointesti.. 20 mei
RBC bleeding
23. Ga 67 gallium citrate tumor imaging 3-5 maiinflammation
24. T 1201 Thalium cardiac imaging 3-5 moi
25. I 125 Labeled hormones, In vitro-tests byantigens,antibo- Radioimmunoassaydies drugs. (commercial kits)-
26. Tc 99m pertechnetate Myocardial o andcerebral perfusionstudies(comercial kits)
i
_ . _______m.____.___~__m_._ _ - _ _ _ . _ _ . - - --_ ---
7.
m
Item 7 INDIVIDUALS RESPONSIBLE FOR' RADIATION SAFETYPROGRAM AND THEIR TRAINING AND EXPERIENCE
7.0 Individual responsible for Radiation SafetyProgram
Evelyn Cintr6n Ruiz, M.D.
Certified in Nuclear Medicine--
by the American. Board ofNuclear Medicine '1976
Responsibilities of authorized userinvolved in medical use
as in item 7.0, 1.-to.4,-page18,regulatory guide 10.8: Revision 2-- o
copy.of previous license is enclosed.-
7.1, 7.3 Authorized user'and Radiation Safety-.Officer:
Evelyn Cintr6n Ruiz, M.D.
Item 8 Training for individuals working-in/orfrecuenting restricted: areas.
Model procedure-in. appendix-A_in'-Regulatory guide 10.8,.page A-1,
* A-2, Revision 2 will-be-followed.
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Nove::,ber 22, 1976,
.
Evelyn 0 intron-huis, LD.f.-84 Ext. !!arianiPonco, Puerto Rico C0751
i
Dear Dr. Cintron-Ruis:
With great plea:ure the Ccnjoint American Board of Nuclear Nedicine-
informs you that you have passed ita' September.16,1976 Certifying '
Damination in the bread . field of Nucicar Medleine- and now are rec.ognized as a Certified Specialist with special competenen :in all-aspects of the diagnostic, therapeutie, and endical research uresof radioactive materials.
A certificate indicating this rec 3gnition will be cent, to you in the-near future,
The Conjoint fanerican Board cf Nuclear Medicine ccrarratulates you-upon your achievement and this recognitten ,.
Sine .e y,
( )-
fJ 3r h J. Ross, M.D.Chairman 7
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| HAD13TIOrt PHYSICIST ,
.
NAME : Daniel Torres Ortiz
ADDRESS : Yaurel B-2 Alt. Mayaguez
Mayaguez, PR 00708 ,
DATE OF BIRTH: July 22, 1936
CIVILIAN STATUS: Married- 3 children
Educafdon:
Bachelor in Sciences (B.S.)-MathematicsCollege Mayague,7-1960
Master Jciences (M.S.)+ Radiological PhysicsUniversity of Puerto Rico-1969
Master Public Administration (M.A.)University of Puerto-1974
Snecial Traininqi
a) Ten weeks Health Physics CourseOakridge Tennessee-1966
b) Regulatory Practices and ProceduresU.S. Atomics Energy Comm..
c) Fundamentals of Occupational Radiation ProtectionU.S. Public Health Service-
d) Instructor Radiological Defense-2 veeks
Work Exporlence:'
1972-Present- Medical Physicist RadiationSafety Officer' -.
".
Mayaguez. Medical Center
In charge of all medical physics work for.a;Radiotherapy and Nuclear Medicine Department.License Number- 52-13598-01
\ 1965-1972- Associate Director-RadiologicalHealth Program-P.R.Department of Health
In charge of all inspections-evaluation ofradiation hazards in Puerto Rico.p
1973-Present- Medical Physics consultant toPonce Oncologic Hospital,
* License Number-52-11832-01
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FACILITIES AND EQUIPMENT-.
.
ATT.9.1-A DRAWING-OF-
| PHYSICAL FACILITIES
AND OTHER INFORMATION..
IS ENCLOSED.-
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CONTAMINATION SURVEY AREAS
AND PORTABLE SURVEY METER. RADI ATION IIVELS
1. Entrance to r.ot Room
' . . Ilot Room (Elutiott Table).
3. Fume llood
4. Ingection Room
$. Labelling Area (Counter Top)
6. . Ibse Calibt atot AreaI
7. Inner llall
8. ocessor Room (Sink)
9. 4mera Imaging
10. Collimat.or Arca j
14. Stretcher'S Area,
12. Uptake Room
13. itall
14. Consultation Office
15. Nurse Station (counter Top)
16. Record Storage
17. Waiting Room
18.-Patlent. Toilet.
_. _ _
9
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%cilities anc r;uipment:'
Nuclear f.edicine facilities are locatec on Grouno floor of thenew Fonce Regional Hospital facilities, in front of previouc!!ocpital builcin6- F.achuelo Kono 14. Poncu
Facilitieu includo:( .icfer to ciaGram of nr'en enclosec.)
.
1. Patient waitin6 room
2. liurse ano accretary utation
5. )'ile storabe area
4. Physician consultation office for film reading andinterview of patients ~~-
*
5. Thyroid uptake anc well counter unit roomt examination-taole
6. fitretchers holoin6 area
7. Dynacamera and computer area; Whole boay eyctem.
.
8. Dark Room ano L16ht Room, with utainloos uteel sink,and automatic Kodak processor
9. Utility room
__ _. _ __ _ . _ _ .
m -
i
_ _ _ - _ _ _ _ - _ _ -
.
..
10. Patien'u irgection room
ll. Nucleat Aedicine hadioactive Lt.bora to ry ; w i th : tainleau
ateel counter, 2 Jtainlesa otoel e,indus where ruaicactive
material will be calibrateo, anc raciopharmaceuticala
will be preparco. Leaa tarier.u ana protective lead carrier
with lead t;1a'.is a re ava ila cle in thin area.
12. Encioac tive storai;c ( or tiot :toota ) cc .aining.; a Fume'ivoci counter covered with formica where isotopes will
on cri;inal lead containers chieldeo by 2 X 4 X8oc kept t
inchea bricks; a protective leaa carrier with leac glacc
is available.
13. A portable survey meter with rant;e up to 1 h/hr anu ano-
ther porta;1e survey meter with Ibnce up to 100 n.r/hrl'or contaminations tests are availaole.
i
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- - - - - - - - - _ _ -_.m__ - ~ _ _ . _ _ . __ . _ _ _ ~ _
. _ _ _ _ _ _ _ . _ . . , . _ . _ _ . _ - -_- . _ . - - _ . _ _ _ _ . _ _ _ - - _ _ _ _ _ . _ __
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.Item 9.2 Survey Instrument Calibration i
'I!
Modol procedure in Appendix U in Regulatory i
Guide 10.8 revision 2 will be-followed. [rt
Item 9.3 Doao Calibrator Calibration f
i
Model procedure in Appendix C, in Regulatory |j Guide 10.8, Revision 2, will be followed.
t
. .
Item 9.4 Personnel Monitoring Program_
!
We will establish and implomont the model L
personnel External Exposure monitoring fprogram published-in Appendix D to-1Regulatory Guido 10.8, revision 2.
.
Item 9.5 N/A
.
Item 9.6 see ATT 9.6 -f
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ATT 9.0"
.
li U C1h; A d c.f..,I ;11 :. ;, e, t:n V I C iW
j [ RADI ATION DETECTIOh Ibb7hUF.E!iTh
I
NANU .t 012 hl,t
., ,
1
1. RM-b Radiation /.onitor noucl 08b-00$ ]itan ;o .18-20 mR/hr- :<adalent e
,
P. Icluxe icotopo Calibrator II 60001 34056Victorcen i uci to 2 curico
3. Victorcen Cutic pio nocol 740 DSurvey meter rando 0-2,500 mr/hr
|
4. Portable curvey motor Mocol 069-701Contamination motor Atomic Productu, Corp.- ]!!cta- Gamma Survey meter 0- 0.5 mR/hr '
1
0- 50 mR/hr
5. Primalent Tm-35 h*uclear anoociates
Radiation monitor Victorcen ,
Nocol 05-437-
Ran6e 1-32 mR/hri
6. Thyroid uptake System II t4odel 187-295:
Atomic Pr ducta,. Corp.Well- Uptake System o
',
't . Picker dynaCamera 4/1Sf37Wholo Body System Dual luotope ;
'with auto peakt-
t3. MDS Computer aya tem 10,000,
Basic A2 Mobile system
q - 9. Automatic Processor- Kodak RP- X omat Processor-
.
I
)'
ti
u
, - _ _ - - _ _ _ . . . _
-
_. - . _ . _ . . _ . _ _ _ - . _ . _ _ _ _ . _ _ . _ . . _ _ . _ - . - _ ~ , . - . . - - . . . . . - _ . - - . - . - _ . _ . _ - . _ . . _ ~ - . _ . _ . , __ -
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Item 10 Rad iation saf ety Program
Item 10.1 Radiation Safety CommitteeRadiation Safety Officer
a. We will issue the.Model Radiation SafetyCommittee Charter and Radiation SafetyOfficer Delegation of Authority that waspublished in Appendix F to Regulatoryguide-10.8, Hovision 2.
b. A Radiation Safety Committee has .boenestablished.'( members enclosed)
10.2 ALARA Program
We will establish and implement'the modelALARA program that was published in Appendix 0to Regulatory Guide 10.6, Revision 2
10.3 Leak test
We will establish and implement the modelprocedure for leak-testing sealed sourcesthat was published in Appnedix H to Regu-latory-Guide 10.8, Revision 2. '
10.4 Safe use of Radiopharmaceuticals
A copy of our rules and-regulations for thesafe use of radiopharmaceuticals is enclosed.
10.5 Spills procedures
We will establish and implement the-modelspill procedures published in Appendix Jto Regulatory Guide 10.8, Revision 2.
10.6 Ordering and' receiving of radioactive material
.A copy of our procedure is enclosed.
__ __ _. _. _ _ _ _ _ _ _ . . _ . - _ _ _ _ . _ _ _
_--.___
. . . .
,
HADIATION SAPETY CC'MITTEE
Membership Requirements *.ccording to.
Nucioar Regulatory Commission Rules and Regulations
Titio 10, CFR, Part 35.22.
i
1. Representative of the institution management
llospital administrator (or medical director)
name Luisa 1.0arrasquil10-
specialty lio n pi ta l administration
Position Administrator
Ponce Regional Hospital
2. Representativo of the nursing staff
Hospital nurse supervisor
name carmen Quinonez n.N.specialty registered nurso
Position- Hospital-nurne supervisor
3. Authorized user in licence =(Nucinar medicino physician)g
name Evelyn cintr6n, M.D.
Position Director-Nuclear Medicino
4. Radiation physicist
namo Danio1'Torres
specialty Radiation physicist
Position Consultant ,
\
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, .
R ADI ATION PROTECTION POLICY / PROCEDURE
Policy: To provide maximal protection aGainst hazard to patientsand personnel when using radioisotopes, by reducing ra-
diation exposure as low as reasonably achievable.
Procedure
1. Never expose a human being to radioactive material for demos-tration purposes only.
.
2. Never remain in hot room for more than necessary during work.
3. Always wear a film badge in Nuclear Medicine Laboratory.
4. Personnel radiation monitoring:
1. Whole body Film badge and TLD ring services will be suppliedregularly for persons working in the laboratory. Reports
of radiation exposures will be evaluated by a member ofthe radioisotope committee (radiologist). Records shouldbe kept for each person.
2. Your film badge radiation monitor is your responsability.
a) film badge'must be worn at all_ times on duty,b) when going off duty, place film badge in assigned area.
c) note badge reading, includin6 cumulativedosa6e monthly.
9. No personnel area iq permitted in radiation areas unless pro-
perly badged and protected.
6. Isolate therapy patients. if hospitalized. Children are not
permitted as visitors. Pregnant visitors or workers are not
PGrmitted. Other personnel and persons keepf3 feet distance,
from patient.
7. Be sure proper verbal comunication with patient is available
and written instructions before therapy'is given re6arding
all these radiation precautions.
. .
_ _ _ _ _ _ _ _ _ _ - - - - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ __ _
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'. .
RADIATION PROTECTf0N PROGRAM:
1.. Isotopes will be used in a precalibrated form.2. For short, half life isotopen obtained from generator, a doec
calibrator is available for assay. Generators are kept for
decay in a separate room kept locked and identified withradiation sign. Radiation sign is posted in the laboratory.
3. When radioactive shipments are received, packaCes should bedelivered to the Nuclear Medioine Laboratory Hot Room. When
processing packa6e, use lead apron gloves, and remote handlingdevice. It should be checked'for damage,breaka6e, or spills.
Check outer containers for contamination, and keep records.
4. Radioisotope material will be kept in isotope lead nest, orin lead-lined refr16erator when indicated,' or in f ootope leadbrick nest. Generator is kept behind lead shield. Prepare
and dispense labeled radiopharmaceuticals behind crystal leadshield. Transport radioactive material in shielded container.
5. Solid radioactive waste should be kept in labeled waste con-
tainer. Keep radioactive solutions in shielded containers,
and identify by labeled compound, radioisotope,date, activity.
6. The laboratory will be surveyed re6ularly for contamination.
Survey program will include the followings
a) Daily routine wipe test in areas used for generator
elution and isotope preparation.
b) Laboratory survey of all areas for contamination with
portable meter or wipe test weekly.
7. personnel will be surveyed frecuently for contamination.
Personnel will use film badges at all times, at chest or
waist level.
8.' Store personnel monitorin6 devices on low back6round areawhen not being worn to measure oc'cupational exposure. Wear
TLD rin6 badges during elution of generator, preparation,
assay, and injection of radiopharmaceuticals.
. . . _ .. _, _ ..- , . . -
7- - - - - - -
_ _ _ _ _ _ _ _ - _ ~
. .
9. Countin6 equipment, enviroment, hands, and clothes should beRadiation back round should bechecked for contamination. 6
checked daily for each instrument and recorde kept.
10. Eating and use of cosmetics will not be allowed in thelaboratory.
11. Smoking is prohibited in radioisotope laboratory areas.
12. No mouth pipetting is permitted. Automatic pipetter will be
used.
13. Remote handling equipment shall be used.
14. Shielding containers will be used when handlinC radioactivematerial for calibration, or when carrying isotope from one
,
place to another.
15. Syringe shields will be used durin6 injection of radioactivematerial.
16. Rubber gloves, Cowns, film badges will be used during manipu-lation and use of isotopes. After handling isotopes wash handsbefore and after removin6 Eloves.
17. Gloves and decontamination solution should be usod for washing
materials.
18. In case of spills, turn off air circulation system, notify all
persons in the room, and the radiation protection officer. In
case of liquids, drop absorbent paper over area, mark areas
with red pencil to indicate contamination. Also refer to
Booklet Emergency Handling of Radiation Accidents, 1972-AEC.
19. Patients should be taken to the Radioisotope Labcratory for
dose administration.
20. Each individual patient dose shall be assayed in the dose
calibrator just prior to administration. For therapeutic
dosos, check patient's name, radionuclide, chemical form,
activity, and refer to written order of physician to administer
dose.
21. The registered nurse trained radioisotope technician or the
Nuclear Medicine technician may calculate and administer
radioisotope doses under supervision of nuclear' medicinephysician.
. . . . - ~ , . ~ . , . . - - . . . , . . , . . ~ . . ~- . . - . - . - , . - _ . . . . . . . . . - . - . . . .
m --
- -
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22. Female patients should be questioned for possibility of' |'
pregnnney. If condition is present, cont,act the attendin6; physician. Itadioactive materials will not ,be administered |
'
to pregnant patients.
23. Hospital personnel will receive instructions regardingprotection against radiation when hospitalized patientsreceive radioisotopes.
24. Only authorized personnel will have access to hot roon.The laboratory will be locked when no personnel is present.
25. Itadiation precaution signa should be posted in areas of .;
fradiation,
26. leicense should be posted on Bulletin Board.
27. Manual of Nucicar Medicine procedures should be available.
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! .. ... m.m . ~ ....._ .. . ... . _ q , .. . . . . _ . . . . .....-,4_............. .
_ _ - _ . _ . _ _ _ . _ . _. ._ _ _ - - . _ . _ - _ _ - . . . _ ._
- _- -. - _ - ____. ._ _. -.... _ . _ - . -
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RAD 10ACTTVE SHIPMENTS
.
1. Arrival of shipments shall-be notified immediately'tolaboratory personnel or physician in charge. Precau-
tions should be taken to avoid unnecesarry exposure toradiation. Packace should be checked for spills orcontamination. Recora cf surveys should be maintained.
.
2. Give written instructions for opening packages-withradioactive materials.
3. Give instructions to follow when receiving packa6es withradioactive materials during off-duty hours.
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4. Inform security personnel and chief nurse supervisor ofthese policies and instructions.
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-- - - - - - - . - _ . . - - - -- - - -.-.- -- - ..-- _ - - _
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PROCEDURES FOR ORDERING AND RECEIVING RADIOACTIVE MATERIAL:
;
I Ordering (,.l
The nurse trained in Nuclear Medicine or the technologist |.
,
will place orders for radioactive materials and will ensure |;
that the requested materials and quantities are authorizedby the licence and that possession limits are not exceeded. !
|*,
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IIA.Routinelyusidmaterials;h~1. Have written record to identify isotope, compound,-
activity levels, supplier, catalog number, date- )
when the radioactive material should be receivedin the Nuclear Medicine Facility.
2. Refer to these written records when opening and
storing the radioactive shipment.
B. Materials for therapeutic use:
1. The nuclear medicine physician who will perform theprocedure will give written-instructions as to isotope,compound, amount of activity level,-and date whenit will be administered. 1
2. The person ordering the material will-make referenceto this written-report when placing the order.
: : -'
3. The physician written request'will be referenced- i,
when receivin6. opening, and storing the material.
4. Assay dose prior to administration.
|C. Maintain records for all ordering and-receipt procedures.-
, _ _ . . _ _ _ . _ . _ _ . _ . . _ . . , _ _ . . , . _ _ . _ . _ _. , _ _ _ . _ . _ . _ . _ . - -
*t- .
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III DELIVERY OF RADIOACTIVE PACKAGES DURING NORMAL WORKINGHOURS:
4.
1. Carriers will be instructed to deliver radioactivepackages directly to Nuclear Medicine Laboratory.
*
2. Arrival of shipments shall be notified inmedf.atelyto laboratory personnel or physician in changi.Precautions ould be taken to avoid unnecessaJy
exposure to radiation. Pa6kage should be checkedfor spills or contamination. Records of surveys
should be maintained.
3. Written instructions for opening packages with
radioactive mate.71als will be given.
IV Instructions to follow when receivin6 radioactive I
shipments during off duty hours
Written instructions will be 6 ven. The security1
personnel and chief nurse supervisor will be informedof these policies and instructions. They will accept
packa6es accordin6 to procedure outlined in memorandumsent to this personnel.
*.
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4
PROCEDURE TO RECEIVE RADIOACTIVE MATERI AL DURING
0)?-DUTY HOURS .
.
a. The Nuclear Medicine trained nurse, chief technologist,
or physician will place all orders for radioactive!
material. Requested materials and quantities will be'
in accordance with the N.R.C. license, and possession'
limits will'not be exceeded,
b. During normal working h,ours carriers will be instructedto deliver radioactive packa6es directly to the
Nuclear Medicine Department,
c. During off-duty hours secur.ity personnel or hospital
nurse General supervisor on duty will accept delivery
of radioactive packages in accordance with procedure
outlined on memorandum instructions sent to these
personnel.
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MEMORA!!DUI',
f
Prom Hospital Administrator ;
From: ;uclear Medicine Director
To: Security Personnel.
Chief !!urse Supervisor
Subject: Receipt of packaces containinC radioactive materialq 4
Any packaces containing radioactive material arrivingtetween 3: 00 PM and 7:00 AM or on Holidays, on Saturdayand Sundays, shall be signed for by the Security Guardor chief hospital nurse supervisor on duty, and takeni
immediately to the nuclear medicine department. Unlockthe door, place the package in the hot room area of thenuclear medicine laboratory, and relock the laboratory .
door.
Precaution: If the package is wet or appears to be damaged,
|immediately contact the hospital Rcdiation Safety Officer( or I;uclcar Medicine Physician) . Ask the carrier to remainat the hospital until it is determined that neither he northe delivery whicle is contaminated.
[9
Radiation Safety Officer
Office Telephone
Home-Telephone,
!?ucicar Medicine Physician
Office Telephone
Home telephone
. _ _ . _ _ . _ _ . . _ . - . . _ . _ . _ . _ _ . _ . . - _ . _ _ . - . - _ . _ _ _ . , . _ . _ - . _ _ _ . . . . . _ .. . , _ , . .
_ _ _ - _ _ _ _ _ _ _ _ _ _ _ .
10.7 opening packages
Copy of procedures for opening packages thatcontain radioactive materials is enclosed.
10.8 Unit dose records
We will establish and implement the modelprocedure for a unit dosage record systemthat was published in Appendix M.1 toRegulatory Guide ~10.8, Revision 2'
10.9 Multidose vial records
We will establish and-implement the modelprocudure for a multidose vial record systemthat was published in Appendix M-2 toRegulatory Guide 10.8, Revision 2.
10.10 Molybdemin Concentration Records
We will establish and implement the model-procedure for measuring and recordingMolybdomin concentration-that was publishedin Appendix M.3 to Regulatory Guide 10.8,Revision 2.
10.11 N/A
10.12 Area Survey Procedures
'We will establish and implement the-modelprocedure for area surveys that was publishedin-Appendix N.to Regulatory Guide 10.8, Hovision 2.
10.13 Air Concentration Control2. Procedure for estimating worker dose'from=
aerosol concentrations.
We will collect' spent aerosol in a shield trapand will follow-manufacturers instructions'ofthe equipment;and materials used.
_ _ _ _ _ _ _ ._ __
____-mm.u__ ._
-
.e, .,.
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PROCEDITHES TO BE FOLLOWED WHEN OPENING pACf: AGES NITH RADIOACTIVE
MATERIALS
1. Inspect packa6e visually for any si6n of damage (wetness,crushed, etc.) If damage is noted, stop procedure and notifyRadiation Safety Officer. Monitor External radiation levelswithin 3 hours after receipt durin6 working hours or within
18 hours of receipt after working hours.
2. Put on gloves to prevent hand contamination.
3. Measure exposure rate at 3 feet from package surface andrecord. If activity greater than 10 MR/hr stop procedure.Notify Radiation Safety Officer.'
4. Measure surface exposure rate and record. If activity greater
than 200 mr/hr stop procedure and notify haciatior. SafetyOfficer.
5. Monitor for surface contamination with wipe test. Notify'
R-diation Officer if contamination exceeds .01 uci/100
6. Open the outer package (follow manufacturers directions) hemovepacking slip. Open innor packaSe to verify contents (comparerequisition, packing slips and label). Check integrity of final
source container (inspect for breaka6e of seals or vials, loss
of liquid, discoloration of packa6e meterial). In case of therapy
doses compare with physicians, written request.
7. Wipe external surface of final source cWaainer with moistenedcotton-swab or wipe test smear, assay and record.
8. Monitor the packing material and packages l'or contaminationbefore discardin6
a. If contaminated, treat as radioactive waste.
b. If not, obliterate radiation' labels before discarding in
regular trash.,
9. Maintain records of results of cheking each package.
. . .. . - . . _ ..._.,..._m.,.....4 ....._.m_. . . . . ~ . . , ,.4 -.
- ___ _ _ _ _
.at. h.*MM4&.444444---+-+M4+4 J +wWeihe4--4.-4 eL J4 awe 46hva 4+...en4'>- 'es4-- @-ek*-. a
.. .. . ,,
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R ADIOACTIVE SHIPMENT RECTIPT REPORT*
| 1. Survey date:Time:Surveyor'
2. Condition of package: .
Ok wetPunctured otherCrushed
,
.
3. Radiation units of label mr/hr,
!
4. Measured radiation levelsa. Package surface mr/hrb. 3 feet from surface mr/hr
,
5. Agreement of packing slip and vial contents:a. Radionuclide yes no difference
b. Amount yes no difference
c. Chem form yes no difference
6. Wipe results: a outer _ countsb. Final Source Container
|
7. Survey results of packin6 material and cartons __mr/hr CPM'
8. Disposition of package af ter inspection
9. If NCR carrier notification required: TimeDatePersons' notified
1!
_
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PONCE DISTRICT HOSPITALNUCLEAR FC:DICINE LABORATORY
SURVEY REPORT
RADIOISOTOPE SHIPMENT
AT UNE FOOT FROM SIDi. .MR/h. . . .
SIDE 1 (ON CONTACT).. ..Mkth. .
" 'SIDE 2 (" ). . !E > n. .
StaE 3 (' ). MR/h"..
"f1DE 4 (" 'e Mh/h. . ..
1sP (" ). .MR/h". .
TOTAL ACTIVITY: eut.e8, _ _ , _ _ _ _
1 N S T R U M E N ' t!c,E D : '
- . _ _._
DATE,__.__ _ ,___
SURVEYED BY;
._,
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10.14 Hadiopharmaceutical therapy
We will establish and implement the model !
procedure for radiation safety during-radio- ,
pharmaceutical therapy that was pubif.shed 1in Appendix P to Rogniatory Guide 10.6, |Revision 2.
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Item 11 Wasto management !.;
11.1 Wasto disposal- ;,
copy of procedure is onclosed.
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WASTE DISPOSAL
A. In older to reduce volur.e of racioactive waste, segregatel
radioactive from non-racioactive waste materials. Give i
instructions to laboratory personnel in this respect.
B. Solid material will be allowed to decay to back round level6
in lead nest used for thic purpose only or in.leaa wasto
container, A storage room will be usea ior cecay of larder
volume of radioactive wastes ana Mo99m/Tc99m generators.
C. Generators Mo99/Tc99m will be kept for decay in the storade
room and labeled with oate they can ce oisposseo off accorcing
to half life of the isotope. Tnu generator columm W.ll besegregated and shoula be monitoren separately for radiationlevel. If still radioactive,it will be kept for a londer
' hen it to in backdrouno l'evelstime-in leau container. *
it is disposued in ordinary trash.
.
D. Liquid material will be kept in or161nal lead protected
vial and allowed to decay to backgrounu 1cvels in lean nest.
Liquida may be disposed also by release into monitory sewerage
in conformance with section 20i303 part 20 Title 10-of code
of Federal regulations.
E. All wastes will be surveyed prior to c:sposal(with all
shieldind removed) hecoroa will be maintainea. The haciation
Safety Committee will review anc implement the acequate
procedures,
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DECAY-IN-STOhAGE ROOM;
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Location: First floor, old nursinC school building .
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Security measures:'
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1- The door is locked at all times.
2- Only Nuclear Medicine personnel, andsecurity or administration personnelwith notification to Nuclear Medicinepersonnel, will have access to the room.
3- Keys are available at Nuclear Medicine ,
Department.
4- Radiation signe are placed on door.!
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LECaY-IN-ST0XAGE h004.
1) Refer to diagram of area to indicate type, location,
shielding available in area in order to reauce raa1ation
levels accordin6 to 10 CFh 20.105. (Permissible levelsof radiation in unrestrictea areas).
2) Security measures for decay-in-utorage area are specifiedand every time material lu-sent for storage.or disposed off.
3) hadiation levels in this area will be surveyea regularly
and recerdeo in ciagram a'teet.
4) Procedure for monitorind waste to assure tnat is hau cecayea
to bacd6rouna levels prior to cisposal:
a. The waste will oe monitorea in a low onckgrouna area.
b. Monitor it with thu G.M. survey portable meter with
range 0-100 mr/ hr, ano usind the-most sensitive ucale.(Survey meter apptopriate for contamination levels),
c. Remove all shielding prior.to monitoring.
d. Keep records of theue surveys au requirea unoer 10 CFR 20.
e. When waste is in background levels-it can_De disposea
off in ordinary trauh.
f. nemove or erace all "racioactive" sions before disposal.
g. All waste will be curveyeo with all snielaind removen'
prior to disposal.
h. Radiation safety of ficer will review anc implement
acequate procedures.
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g,sguemmerevreawrc ercewerrexwcrecresweryt=w.tyr''.y as u.s. Nucst An neoutatony couuissroe. ' ' ' ' ' D' '' ^ ' t S
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4( MATERIALS LICENSE Amendment No. $ ;,
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f '\suant to the Atomic Energ Act of 1954, as an ended, the Energ Reorgarotation Act of 1974 (Pubhc Law 93-438).and Title 10.|g , /Je of Iedetal Reguleth.ns. Chapter 1. Paits 30,31,37,33,34,35,40 and 7') and in rehahce on staternents and representstions
4| htretufore made by the lice. net, a hcense is hereby lssued authorizing the licensee to reteht. acquise, possess, and transfer byproduct.y
g4 nurce, and special nuclear rnaterial designated below; w use such material for the purpose {s)and at the place (s) designated below ;toy4' debier or trarafer such enaterial to persons authorized to recche it in accordance with the regulations of the appbcable Part(s) Thisk license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 19$4 as amended, and isI
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f| subget to all applicable rules, regnistians and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any|4 conditions specified below.
f - yLkensee In accordance with application I
:,1 dated July 30, 1985,|4 i~ Ponce District llospital 52-11534-01 is amended1 L nse ntN in NS enD N ty to read as follows: y
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( 2' Mechuelo Road 14Ponce, Puerto Rico 00731 b g k g.- I
February 23, 1991|
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l,~1 ()r 0-03527y 4
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Reference No.6.11 product, source, and/or 7. Chemical and/or physical < k Maaimum menout t that licensee3
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h spec!al nuclear material form - h.imay possess at any one timeI
Q \+ %4, C
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6/ ,4pde this beente I! 4i ,2: O. |J s.A. $e cw
h{A.
material listed NAny byproduct adige rs A. A etessary for
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nacekli.c A:. ; )(i
[ti) in Groups 1 and p ,. $(14 6d-fTit14f--[# g) 4 u. authorized inj
SQ~1 tem 9.A.>,11 of Schedule A, k WB
M I'.,,,'' ' ,TT Section35.100of@ P
Sc'h'
h 10 CFR 35r h 5 h
{ h 3[e1$~-%/.' . / d h
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k 5'ec t' i H D > ?' - k h'
g/ AnI. fqrinlj0rdbp? k f/ptB Any byproduct B. C 2 curies of each >B.k. material listed O
M byproduct material|-
ilisted l a
@hin Group 111 111 of Schtdule A, gv authorized inof Schedule A, h Section 35.100 D Subitem 6.B. [yi Section 35.100
%.10ffR[35 I g'pi) of 10 CFR 35 yh pNW$ C. Any byproduct C. Any C. 3 millicuries of F
{Wmaterial listedin Section 31.11(a)
each byproduct kmaterial authorized f!< of 10 CFR 31 in Subitem 6.C.
i D. lodine 131 D. lodidt D. As necessary for$
f(uses authorized inSubitem 9.D.
a
4 9. Authorized usei y
)'l A. Any diagnostic procedure listed in Groups I and 11 of Schedule A, Section >35.100 of litle 10, Code of federal Regulations., r
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tMATERIAL.5 LICENSE b2-11534-01 isureLt ME NT AR Y SHE F T g ,,,, g ,,, ,,, g ,, g-~
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-} 030-03$27 8, u--
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Amendment No. 05,
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(Cont'd authorized use) 1
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ID. Preparation and use of radiopharmaceuticals for any diagnostic procedure I
listed in Group III of Schedule A, Section 35.100 of Title 10, Code of iFederal Regulations. i
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C. In vitro studies.- I~
[D. Treatment of hyperthyroidism, Car i d o and ' thyroid carcinoma.
A |s I~ '
CONDITIONS-,
10. Licensed material h l) b ed only at Ponce Distfho , Mal,MachueloRoad14,f( Ponce,PuertoRiccQi O #g I;ibhall be u3e \ ig {bppyrvisiongC l
r R%4 11. Licensed materia hg or Ander4 l|, Evelyn Cintron R , M.D. iy f., .{ ,1 Ig,|12. For a period noi, Ao e fd kib in- my- .alf r / yea'r, ahisiting physician !'4 is authorized to%fse 1 As % 1 L lo r, hMan *u,se;dnderghe terms of this'4 ilcense, provided ",Aic vi 3>h i u 1 .
I' i) 6 ' N ||W .h Nw
W'\of Y papital's A. Has the prioMritt l ''
s dministrator and IRadiation Safet, ommi tee, nd /.,
gB. Is specifically hM as a user' on a Nucle hgulatory Commission|| license authorizing 5t/an use, and gi
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duks hikt ' physician is specificallyC. Performs only those pro
t authorized to perform pursuant to a license issued by the Nuclear| -
4Regulatory Commission.
j The licensee shall maintain for inspection by the Commission copies of thewritten permission specified1; iin A. above and of the license (s) specified t; in B. and C. above for a period of 5 years from the date permission is Ig granted under A. above.{+
4 13. The licensee is authorized to hold radioactive material with a physicalt|
4 half-life of less than 65 days for decay-in-storage beiore disposal in i
,
$, ordinary trash provided:'
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3 I| -A. Radioactive waste to be disposed of in this manner shall be held for|j( decay a minimum of 10 half-lives.
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MATERIALS LICENSESUPPLEME NT ARY SHE ET
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030-0{5?7'
Amendment No. 05- -
' (Cont'tO CONDIT10NSe
h B. Before disposal as normal waste, radioactive waste shall be surveyedy to determine that its radioactivity cannot be distinguished fromkg background.
All radiation labels shall be removed or obliterated. <r
fl' C. Generator columns shall be segregated so that they may be mcnitored'
.
separately to ensure decay to backgr.ound levels prior,to disposal.
f14. bQbthPatients containing Iodine[idualactivity. of thyrdid- carcinoma shallremain hospitalized until
O illicuries 6r less.$ 15. Except as spec.ifical provided otharvise .in this nse, the licenseei shall conduct its - rain in accordance with the st nts representa-b tions, and procedufe (,cotained in the documents inc-1 Ag a,y enclosures,th listed below. n
s tateQa ' ache 'gulatory Commissio 8 'Er6 u i|tJons shall governTh MY unless the t 9
ts, eqtations and Iddres in the licensee's l'4| applicationandc[qespondene stri t' ( Athan the (hulations.L re' morF. $ 's '/ .$ 74- A. ApplicationNted f T . { } k 5, O
'' July 3 985 / ,''
B. Therapy proce e, dt%fd th .. U > dgram datedt k-
~ January 3M1986
Y[k /[h|''
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CQC. ALARA Program d QF 4
'. January 31,198h D! Y St$ MdR
;FOR THE U.S. NUCLEAR KLGULATORY COMMISSION
fEARL G. VRIGHT
Date # By [ N'_ 9.
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Region 11 Nuclear MatatialsaSafety Sectfan
101 Marietta Street, Suite 2300Atlanta, GA 30323
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uni 1ED ST ATES[pm #8cg%, NOC(. EAR REGULATORY COMMISSION
.? * ~# RE0lON 11j h 101 M ARitiT A ST RE ET , N.W.#* # Att ANT A.Of 0A0l A 30173
\' / rFEB 12199'
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Ibnw District (Pegional) lbspital O(/4N1'Iti: Inisa Carrarquillo r
D<cottive Dinrtnr )
thchuelo Ibad 14i Ponm , PR 00731 Docket No. 030-03527
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License No. 52-11534-01Control No. 253936
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Gentlemen:[
SUBJECT: LICENSE RENEWAL APPLICATION
This is to acknowledge receipt of your application for renewal of the nuclearmaterial license Identified above. Your application is deemed timely filed, andaccordingly, the license will not expire until final action has been taken bythis offics.
Any correspondence regarding your renewal application should reference thecentrol number and license number specified above.
Sincerely,
[ar$id,|Vluf|tVNuclear Materials safety SectionDivision of Radiation Safety.
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,,and Safeguards4
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NHS-1 (1/85)
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